Common use of MANUFACTURING SUPPLY AND APPLICABLE STANDARDS Clause in Contracts

MANUFACTURING SUPPLY AND APPLICABLE STANDARDS. 2.1 During the Term CMC shall manufacture and deliver Product in the quantity of Batches that are the subject of a Firm Order pursuant to the forecast mechanism set out in Clause 5 and in accordance with the standards and requirements set out herein. 2.2 Customer shall purchase all quantities of Product ordered from CMC and which are the subject of a Firm Order on the terms of this Agreement for the Batch Price per Batch plus any Additional Charges for the Batch. During the Term, Customer shall, and where it or its Affiliates are obliged to supply any of their partners’ and their Affiliates’ requirements for Product it shall ensure that it and its Affiliates only source and obtain such Product from CMC other than where otherwise permitted under Clause 5.17.4 in the event of a Supply Failure. Customer shall use reasonable efforts to procure that its partners, and their respective Affiliates shall only source and obtain FIX Product from CMC. Commercial Supply Agreement – JUNE 2011 14 2.3 CMC shall act diligently and shall apply its reasonable professional standards and use its Commercially Reasonable Endeavors (the “Standard”) in its performance of the Services and discharge of its obligations under this Agreement to: 2.3.1 undertake the Services in accordance with the Forecast and projected Delivery dates; and 2.3.2 manufacture, in compliance with the Specification and cGMP, the Commercial Quality Agreement and all Applicable Laws, those quantities of Batches of Product that are the subject of a Firm Order using the same Process that has previously been used by CMC to manufacture the Product in accordance with the Specification. 2.4 CMC shall retain and store samples of all Product released by CMC’s quality department with a Certificate of Analysis under this Agreement for such period as may be required by applicable Regulatory Obligations, which in the absence of a definitive time period shall be fifteen (15) years from the date of release or Delivery (whichever is the earlier). If the Parties agree, CMC shall retain such samples for a longer period at the Customer’s expense and CMC’s then current rates. 2.5 CMC may subcontract: 2.5.1 to Testing Laboratories proposed by CMC (and approved by Customer, such approval not to be unreasonably withheld or delayed) only those parts of the Services identified in Appendix One or such other part(s) of the Services approved by Customer (such approval not to be unreasonably withheld or delayed); or 2.5.2 to any other third party, any part(s) of the Services with the prior written consent of Customer (such consent not to be unreasonably withheld, delayed or conditioned); provided that, in any case CMC shall remain responsible for the activities of the party to whom that part(s) of the Services is subcontracted and for compliance of its subcontractors with the requirements of this Agreement, and all Applicable Laws to the same extent that CMC would be responsible if CMC were doing such work directly. Nothing herein shall constitute any contractual relationship between Customer and any subcontractor of CMC or any direct obligation between Customer and such subcontractor to pay, or be responsible for the payment of, any sums to any such subcontractors but Customer shall remain responsible to CMC for payment of the Price plus any Additional Charges. Commercial Supply Agreement – JUNE 2011 15

MANUFACTURING SUPPLY AND APPLICABLE STANDARDS. 2.1 During the Term CMC shall manufacture and deliver the Product in the quantity of Batches that are the subject of a Firm Purchase Order pursuant to the forecast mechanism set out in Clause Section 5 and in accordance with the standards terms, standards, Specifications, Timeline and requirements set out herein. 2.2 in this Agreement. Customer shall purchase all quantities of Product ordered from CMC and which are the subject Product in the quantity of a Firm Order on Batches in accordance with the terms of this Agreement for the Batch Price per Batch plus any Additional Charges for the Batch. During the Term, Customer shall, and where it or its Affiliates are obliged to supply any of their partners’ and their Affiliates’ requirements for Product it shall ensure that it and its Affiliates only source and obtain such Product from CMC other than where otherwise permitted under Clause 5.17.4 in the event of a Supply Failure. Customer shall use reasonable efforts to procure that its partners, and their respective Affiliates shall only source and obtain FIX Product from CMC. Commercial Supply Agreement – JUNE 2011 14Agreement. 2.3 2.2 CMC shall act diligently and shall apply its reasonable professional standards and use its Commercially Reasonable Endeavors (the “Standard”) Standard in its performance of the Services and discharge of its obligations under this Agreement to: 2.3.1 to undertake the Services. 2.3 The Parties shall agree upon a Commercial Quality Agreement and the forms of Certificate of Analysis and Certificate of Compliance within ninety (90) days of the Effective Date. 2.4 CMC shall perform the Services in compliance with all applicable laws and regulations, including the applicable Regulatory Obligations and FDA guidelines. Without limiting the foregoing, where the relevant stage of the Services defines the performance of that stage to be in accordance with cGMP standards, then CMC shall comply with the applicable cGMP criteria for the performance of that stage and shall obtain the validation of the CMC Facilities to do so in accordance with the Forecast Work Statement. Where applicable CMC shall comply with the obligatory requirements stipulated in the International Conference on Harmonisation guidelines on quality. CMC shall be solely responsible for the maintenance and projected Delivery dates; and 2.3.2 manufacture, storage of the Raw Materials and any Customer Materials (including the Cell Banks) under appropriate conditions in compliance with cGMP requirements, and for the Specification qualification of the Raw Materials and cGMPany Customer Materials prior to their use in the manufacturing process, the Commercial Quality Agreement and all Applicable Laws, those quantities of Batches of Product that are the subject of a Firm Order using the same Process that has previously been used by CMC to manufacture the Product in accordance with the Specification. 2.4 Commercial Quality Agreement, Master Batch Record, SOPs, and the Specifications. CMC shall retain and store samples of all cGMP Product released by CMC’s 's quality department with a Certificate of Analysis and a Certificate of Compliance under this Agreement under appropriate conditions and for such period as may be required by applicable Regulatory Obligations, which in the absence of a definitive time period shall be fifteen (15) years from the date of release or Delivery (whichever is the earlier)[*]. If the Parties agree, CMC shall retain such samples for a longer period at the Customer’s expense 's cost. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and CMC’s then current ratesfiled separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 2.5 CMC may subcontract: 2.5.1 subcontract to Testing Laboratories proposed by CMC (and approved by Customer, such approval not to be unreasonably withheld or delayed) only those parts of the Services identified in Appendix One or such other part(s) of the Services approved by Customer (such approval not to be unreasonably withheld or delayed); or 2.5.2 to any other third partyits Affiliates, any part(s) of the Services Testing Laboratory or, with the prior written consent of Customer (such consent not to be unreasonably withheldCustomer, delayed or conditioned)any other third party; provided that CMC may not change the subcontracted party nor introduce a new subcontracted part(s) of the Services which may require Customer to update or amend any regulatory filings for the Product; provided further that, in any case CMC shall remain responsible for the activities of the party subcontractor to whom that part(s) of the Services is subcontracted and for compliance of its subcontractors shall enter into written agreement with such subcontractor and ensure that such subcontractor complies with the requirements of obligations under this AgreementAgreement applicable to such subcontractor’s activities (including without limitation confidentiality and non-use obligations, intellectual property assignment obligations, compliance and all Applicable Laws to the same extent that CMC would be responsible if CMC were doing such work directly. Nothing herein shall constitute any contractual relationship between Customer quality-related obligations and any subcontractor of CMC or any direct obligation between Customer record keeping obligations and such subcontractor to pay, or be responsible permission for the payment of, any sums to any such subcontractors but Customer shall remain responsible to CMC access for payment of the Price plus any Additional Charges. Commercial Supply Agreement – JUNE 2011 15audit by Customer).

MANUFACTURING SUPPLY AND APPLICABLE STANDARDS. Commercial Supply Agreement 244238347 v3 2.1 During the Term CMC shall use Commercially Reasonable Efforts to manufacture Product: (a) according to the Process; (b) that meets Specifications; (c) in compliance with Applicable Laws and deliver Regulatory Obligations; and (d) in accordance with the terms of this Agreement and the Commercial Quality Agreement. 2.2 During the Term, CMC shall use Commercially Reasonable Efforts to manufacture Product in the quantity of Batches that are the subject of a each Firm Order and Semi-Firm Order pursuant to the forecast mechanism set out in Clause 5 and in accordance with the standards terms and requirements set out herein. 2.2 in this Agreement. Customer shall purchase all quantities of Product ordered from CMC and which are CMC shall supply to Customer the subject Product in the quantity of a Firm Order on Batches in accordance with the terms of this Agreement for the Batch Price per Batch plus any Additional Charges for the Batch. During the Term, Customer shall, and where it or its Affiliates are obliged to supply any of their partners’ and their Affiliates’ requirements for Product it shall ensure that it and its Affiliates only source and obtain such Product from CMC other than where otherwise permitted under Clause 5.17.4 in the event of a Supply Failure. Customer shall use reasonable efforts to procure that its partners, and their respective Affiliates shall only source and obtain FIX Product from CMC. Commercial Supply Agreement – JUNE 2011 14Agreement. 2.3 CMC will comply with quality standards as agreed to in the Commercial Quality Agreement. 2.4 CMC shall act diligently maintain a completed Drug History Record and shall apply its reasonable professional standards and use its Commercially Reasonable Endeavors (the “Standard”) such other records as specified in its performance of the Services and discharge of its obligations under this Agreement to: 2.3.1 undertake the Services in accordance with the Forecast and projected Delivery dates; and 2.3.2 manufacture, in compliance with the Specification and cGMP, the Commercial Quality Agreement and all Applicable Laws, those quantities for the period of Batches of Product that are time specified in the subject of a Firm Order using the same Process that has previously been used by CMC to manufacture the Product in accordance with the Specification. 2.4 Commercial Quality Agreement. CMC shall retain and store samples of all Quality Released Product released by CMC’s quality department with a Certificate of Analysis under this Agreement for such period as may be required by applicable Applicable Laws and Regulatory ObligationsObligations and the Commercial Quality Agreement, which in the absence of a definitive time period shall be fifteen (15) years [***] from the date of release or Delivery (whichever is the earlier)Delivery. If the Parties agree, CMC shall retain such samples for a longer period at the Customer’s expense and CMC’s then current rates's cost. 2.5 CMC may subcontract: 2.5.1 to Testing Laboratories proposed by CMC its Affiliates, any part of the Services (and approved by Customer, such approval provided that the Affiliates may not to be unreasonably withheld or delayed) only further subcontract those parts of the Services identified in Appendix One or such other part(s) of the Services approved by Customer (such approval not to be unreasonably withheld or delayedServices); or 2.5.2 to any other third party, any part(s) of the Services with the prior written consent of Customer (such consent not to be unreasonably withheld, delayed or conditioned); 2.5.2 to Testing Laboratories; and; 2.5.3 to any other reputable qualified Third Party, any part(s) of the Services (provided thatCMC identifies the specific Services to be performed) with the prior written consent of Customer (such consent not to be unreasonably withheld, in any case delayed or conditioned). CMC shall remain responsible for the activities of the party Services to be rendered by Third Parties to whom that part(s) of the it subcontracts and shall ensure such Third Parties perform such subcontracted Services is subcontracted and for in compliance of its subcontractors with the requirements terms and conditions of this Agreement, and all Applicable Laws to the same extent that CMC would be responsible if CMC were doing such work directly. Nothing herein shall constitute any contractual relationship between Customer and any subcontractor of CMC or any direct obligation between Customer and such subcontractor to pay, or be responsible for the payment of, any sums to any such subcontractors but Customer shall remain responsible to CMC for payment of the Price plus any Additional Charges. Commercial Supply Agreement – JUNE 2011 15.

MANUFACTURING SUPPLY AND APPLICABLE STANDARDS. 2.1 During the Term CMC Term: 2.1.1 AGC shall use [***] to manufacture and deliver Product in the quantity of Batches that are the subject of a Firm Order pursuant to the forecast mechanism set out in Clause 5 and in accordance with the standards terms and requirements set out herein. 2.2 in this Agreement. Customer shall purchase all quantities from AGC the Product in the quantity of Product ordered from CMC and which are the subject of a Firm Order on Batches in accordance with the terms of this Agreement for Agreement. 2.1.2 Notwithstanding the Batch Price per Batch plus any Additional Charges for the Batch. During the Term, Customer shallforegoing, and where it or its Affiliates are obliged without reference to [***], AGC will manufacture and supply any of their partners’ and their Affiliates’ requirements for Product it shall ensure that it and its Affiliates only source and obtain such Product from CMC other than where otherwise permitted under Clause 5.17.4 in the event of a Supply Failure. Customer shall use reasonable efforts to procure that its partners, and their respective Affiliates shall only source and obtain FIX Product from CMC. Commercial Supply Agreement – JUNE 2011 14 2.3 CMC shall act diligently and shall apply its reasonable professional standards and use its Commercially Reasonable Endeavors (the “Standard”) in its performance of the Services and discharge of its obligations under this Agreement to: 2.3.1 undertake the Services in accordance with the Forecast and projected Delivery dates; and 2.3.2 manufacture, in compliance with the Specification and cGMP, the Commercial Quality Agreement and all Applicable Laws, those quantities of Batches of Product that are the subject of a Firm Order using the same Process that has previously been used by CMC to manufacture the Product hereunder in accordance with the Specification, cGMP and the Regulatory Obligations. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED COMMERCIAL SUPPLY AGREEMENT 2.1.3 If Customer wishes to extend the scope of the Regulatory Obligations to cover jurisdictions beyond [***], the Parties will discuss in good faith an amendment to this Agreement to do so. If the Parties do not execute such an amendment on mutually agreeable terms within [***] days of Customer’s written request to do so, then Customer will have the right to have its requirements of BDS and Product solely for such jurisdiction manufactured by a Third Party, or to do so itself or through an Affiliate, notwithstanding any other provision of this Agreement. 2.2 Where applicable, AGC will comply with the obligatory requirements stipulated in the International Conference on Harmonisation guidelines on quality. 2.3 AGC and Customer’s Affiliate Horizon Pharma Tepro, Inc. (“Horizon Tepro”) have entered into that certain quality agreement dated October 10, 2017. Promptly following the Effective Date, but in any event within [***] days following the Effective Date unless mutually extended by the Parties, AGC and Horizon Tepro shall execute an amendment to such quality agreement in order to assign such quality agreement from Horizon Tepro to Customer and to address the manufacture of Product under this Agreement. Upon the execution of such amendment, such quality agreement shall be deemed to be the Commercial Quality Agreement. AGC will comply with quality standards as agreed to in the Commercial Quality Agreement. Any material breach of the Commercial Quality Agreement related to a quality matter will be deemed to be a material breach of this Agreement. 2.4 CMC AGC shall retain and store samples of all cGMP Product released by CMCAGC’s quality department with a Certificate of Analysis under this Agreement for such period as may be required by applicable Regulatory Obligations, which in the absence of a definitive time period shall be fifteen (15) [***] years from the date of release or Delivery (whichever is the earlier)Delivery. If the Parties agree, CMC AGC shall retain such samples for a longer period at the Customer’s expense cost. AGC will notify Customer in writing before disposing of any such samples and CMCCustomer will have the right to have such samples delivered to Customer or its designee at Customer’s then current ratesexpense. 2.5 CMC AGC may subcontract: 2.5.1 to Testing Laboratories proposed by CMC its Affiliates, any part of the Services (and approved by Customerprovided that the Affiliates may not further subcontract those parts of the Services), with the prior written consent of Customer (such approval consent not to be unreasonably withheld withheld, delayed or delayed) only those parts of conditioned); 2.5.2 to Testing Laboratories which the Customer has approved in writing, Services identified in the applicable Appendix One or as Services which AGC may subcontract to such other part(s) of the Services approved by Customer (such approval not to be unreasonably withheld or delayedTesting Laboratory(ies); or; 2.5.2 2.5.3 to any other third partyThird Party, any part(s) of the Services with the prior written consent of Customer (such consent not to be unreasonably withheld, delayed or conditioned); provided that, in any case CMC . AGC shall remain directly and fully responsible to Customer for the activities of the party Person to whom which it subcontracts any of the Services. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED COMMERCIAL SUPPLY AGREEMENT 2.6 The Services described in this Agreement, subject to any written agreement or amendment to the contrary, are the only services to be performed by AGC hereunder. Due to the nature of the Services, changes to the Services may be necessary. Customer acknowledges this potential necessity and recognizes that part(s) of any changes to Services may change the price for such Services. 2.7 If additional Services or a change to the Services is subcontracted and for compliance of its subcontractors necessary, then the Parties shall promptly meet in good faith to negotiate with the requirements of this Agreement, and all Applicable Laws to the same extent that CMC would be responsible if CMC were doing such work directly. Nothing herein shall constitute any contractual relationship between Customer and any subcontractor of CMC or any direct obligation between Customer and such subcontractor to pay, or be responsible for the payment of, any sums respect to any such subcontractors but Customer shall remain responsible changes as may be necessary. Any such changes do not become effective until set forth in an amendment to CMC for payment this Agreement or other written agreement signed by an authorized representative of the Price plus any Additional Charges. Commercial Supply Agreement – JUNE 2011 15each Party.

MANUFACTURING SUPPLY AND APPLICABLE STANDARDS. 2.1 During the Term Term, CMC shall use Commercially Reasonable Efforts to manufacture Product: (a) that meets Specifications; (b) in compliance with Applicable Laws and deliver Regulatory Obligations; and (c) in accordance with the terms of this Agreement and the Commercial Quality Agreement. 2.2 During the Term, CMC shall use Commercially Reasonable Efforts to manufacture Product in the quantity of Batches that are the subject of a each Firm Order and Semi-Firm Order pursuant to the forecast mechanism set out in Clause 5 and in accordance with the standards terms and requirements set out herein. 2.2 in this Agreement. Customer shall purchase all quantities of Product ordered from CMC and which are CMC shall supply to Customer the subject Product in the quantity of a Firm Order on Batches in accordance with the terms of this Agreement for the Batch Price per Batch plus any Additional Charges for the Batch. During the Term, Customer shall, and where it or its Affiliates are obliged to supply any of their partners’ and their Affiliates’ requirements for Product it shall ensure that it and its Affiliates only source and obtain such Product from CMC other than where otherwise permitted under Clause 5.17.4 in the event of a Supply Failure. Customer shall use reasonable efforts to procure that its partners, and their respective Affiliates shall only source and obtain FIX Product from CMC. Commercial Supply Agreement – JUNE 2011 14Agreement. 2.3 CMC shall act diligently maintain a completed Drug History Record and shall apply its reasonable professional standards and use its Commercially Reasonable Endeavors (the “Standard”) such other records as specified in its performance of the Services and discharge of its obligations under this Agreement to: 2.3.1 undertake the Services in accordance with the Forecast and projected Delivery dates; and 2.3.2 manufacture, in compliance with the Specification and cGMP, the Commercial Quality Agreement and all Applicable Laws, those quantities for the period of Batches of Product that are time specified in the subject of a Firm Order using the same Process that has previously been used by CMC to manufacture the Product in accordance with the Specification. 2.4 Commercial Quality Agreement. CMC shall retain and store samples of all cGMP Product released by CMC’s quality department with a Certificate of Analysis under this Agreement for such period as may be required by applicable Applicable Laws and Regulatory ObligationsObligations and the Commercial Quality Agreement, which in the absence of a definitive time period shall be fifteen (15) years from the date of release or Delivery (whichever is the earlier)Delivery. If the Parties agree, CMC shall retain such samples for a longer period at the Customer’s expense and CMC’s then current rates.'s cost. COMMERCIAL SUPPLY Agreement 2.5 2.4 CMC may subcontract: 2.5.1 2.4.1 to Testing Laboratories proposed by CMC its Affiliates, any part of the Services (and approved by Customer, such approval provided that the Affiliates may not to be unreasonably withheld or delayed) only further subcontract those parts of the Services identified in Appendix One or such other part(s) of the Services approved by Customer (such approval not to be unreasonably withheld or delayedServices); or 2.5.2 to any other third party, any part(s) of the Services with the prior written consent of Customer (such consent not to be unreasonably withheld, delayed or conditioned); ; 2.4.2 to Testing Laboratories, with the prior written consent of Customer (such consent not to be unreasonably withheld, delayed or conditioned) and; 2.4.3 to any other reputable qualified Third Party, any part(s) of the Services (provided thatCMC identifies the specific Services to be performed) with the prior written consent of Customer (such consent not to be unreasonably withheld, in any case delayed or conditioned). CMC shall remain responsible for the activities of the party Services to be rendered by Third Parties to whom that part(s) of the it subcontracts and shall ensure such Third Parties perform such subcontracted Services is subcontracted and for in compliance of its subcontractors with the requirements terms and conditions of this Agreement, and all Applicable Laws to the same extent that CMC would be responsible if CMC were doing such work directly. Nothing herein shall constitute any contractual relationship between Customer and any subcontractor of CMC or any direct obligation between Customer and such subcontractor to pay, or be responsible for the payment of, any sums to any such subcontractors but Customer shall remain responsible to CMC for payment of the Price plus any Additional Charges. Commercial Supply Agreement – JUNE 2011 15.

MANUFACTURING SUPPLY AND APPLICABLE STANDARDS. 2.1 During the Term CMC shall manufacture and deliver the Product in the quantity of Batches that are the subject of a Firm Purchase Order pursuant to the forecast mechanism set out in Clause Section 5 and in accordance with the standards terms, standards, Specifications, Timeline and requirements set out herein. 2.2 in this Agreement. Customer shall purchase all quantities of Product ordered from CMC and which are the subject Product in the quantity of a Firm Order on Batches in accordance with the terms of this Agreement for the Batch Price per Batch plus any Additional Charges for the Batch. During the Term, Customer shall, and where it or its Affiliates are obliged to supply any of their partners’ and their Affiliates’ requirements for Product it shall ensure that it and its Affiliates only source and obtain such Product from CMC other than where otherwise permitted under Clause 5.17.4 in the event of a Supply Failure. Customer shall use reasonable efforts to procure that its partners, and their respective Affiliates shall only source and obtain FIX Product from CMC. Commercial Supply Agreement – JUNE 2011 14Agreement. 2.3 2.2 CMC shall act diligently and shall apply its reasonable professional standards and use its Commercially Reasonable Endeavors (the “Standard”) Standard in its performance of the Services and discharge of its obligations under this Agreement to: 2.3.1 to undertake the Services. 2.3 Under the Original CSA, the Parties have agreed upon a Commercial Quality Agreement and the forms of Certificate of Analysis and Certificate of Compliance, which shall continue to apply to the Services to be performed under this Agreement, unless otherwise agreed by the Parties in writing. 2.4 CMC shall perform the Services in compliance with all applicable laws and regulations, including the applicable Regulatory Obligations and FDA guidelines. Without limiting the foregoing, where the relevant stage of the Services defines the performance of that stage to be in accordance with cGMP standards, then CMC shall comply with the applicable cGMP criteria for the performance of that stage and shall obtain the validation of the CMC Facilities to do so in accordance with the Forecast Work Statement. Where applicable CMC shall comply with the obligatory requirements stipulated in the International Conference on Harmonisation guidelines on quality. CMC shall be solely responsible for the maintenance and projected Delivery dates; and 2.3.2 manufacture, storage of the Raw Materials and any Customer Materials (including the Cell Banks) under appropriate conditions in compliance with cGMP requirements, and for the Specification qualification of the Raw Materials and cGMPany Customer Materials prior to their use in Commercial Supply Agreement 12 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Commercial Quality Agreement Securities and all Applicable LawsExchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, those quantities of Batches of Product that are as amended. the subject of a Firm Order using the same Process that has previously been used by CMC to manufacture the Product manufacturing process, in accordance with the Specification. 2.4 Commercial Quality Agreement, Master Batch Record, SOPs, and the Specifications. CMC shall retain and store samples of all cGMP Product released by CMC’s 's quality department with a Certificate of Analysis and a Certificate of Compliance under this Agreement under appropriate conditions and for such period as may be required by applicable Regulatory Obligations, which in the absence of a definitive time period shall be fifteen (15) years from the date of release or Delivery (whichever is the earlier)[*]. If the Parties agree, CMC shall retain such samples for a longer period at the Customer’s expense and CMC’s then current rates's cost. 2.5 CMC may subcontract: 2.5.1 subcontract to Testing Laboratories proposed by CMC (and approved by Customer, such approval not to be unreasonably withheld or delayed) only those parts of the Services identified in Appendix One or such other part(s) of the Services approved by Customer (such approval not to be unreasonably withheld or delayed); or 2.5.2 to any other third partyits Affiliates, any part(s) of the Services Testing Laboratory or, with the prior written consent of Customer (such consent not to be unreasonably withheldCustomer, delayed or conditioned)any other third party; provided that CMC may not change the subcontracted party nor introduce a new subcontracted part(s) of the Services which may require Customer to update or amend any regulatory filings for the Product; provided further that, in any case CMC shall remain responsible for the activities of the party subcontractor to whom that part(s) of the Services is subcontracted and for compliance of its subcontractors shall enter into written agreement with such subcontractor and ensure that such subcontractor complies with the requirements of obligations under this AgreementAgreement applicable to such subcontractor’s activities (including without limitation confidentiality and non-use obligations, intellectual property assignment obligations, compliance and all Applicable Laws to the same extent that CMC would be responsible if CMC were doing such work directly. Nothing herein shall constitute any contractual relationship between Customer quality-related obligations and any subcontractor of CMC or any direct obligation between Customer record keeping obligations and such subcontractor to pay, or be responsible permission for the payment of, any sums to any such subcontractors but Customer shall remain responsible to CMC access for payment of the Price plus any Additional Charges. Commercial Supply Agreement – JUNE 2011 15audit by Customer).